using data analysis and Six Sigma methodologies. Coordinate installation, validation (IQ/OQ/PQ), and optimisation of new...
performance, distribution, and decontamination issues. Author and execute Performance Qualification (PQ) protocols for isolator... placement and worst-case challenge strategies. Experience authoring and executing PQ protocols and preparing final validation...
Qualification), OQ (Operational Qualification) and PQ (Performance Qualification). Independently write and review qualification...
validation activities during DQ, FAT, IQ, OQ, SAT and PQ phases. Establish, manage, and maintain automation project budgets...
and/or support IQ, OQ, PQ activities. Quality Systems & Compliance Develop, maintain, and approve SOPs, work instructions...
teams in the production environment along with using troubleshooting techniques to solve PQ related issues. KEY DUTIES...
within a medical device or manufacturing environment Experience with root cause analysis and process validation (IQ, OQ, PQ) Strong...
documentation for equipment DQ, IQ, OQ, PQ validations. Conduct effective design reviews of new equipment at all stages...
) principles Subject matter expert in the ability to coordinate qualification activities (PPAP, IQ, OQ, PQ, DOE, etc.) to meet...
including validation plans, URS, FS, DS, risk assessments, IQ/OQ/PQ protocols, and summary reports. Ensure compliance with FDA.... Experience authoring and executing IQ/OQ/PQ protocols and validation documentation. Strong understanding of risk-based...